M19-130 Clinical Research Study
A Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Patient Benefits
Patients who screen and then enroll in the study will receive:
- Study drug (active, comparator or placebo), lab work, and visits included at no cost.
- Patients will be reimbursed $90.00 per completed study visit for transport costs.
Study Duration for Patients
The total study duration is approximately 48-weeks which consists of approximately 15 visits during the course of the study.
The study consists of three periods:
- Screening Period (Up to 42 day before the treatment starts) to see if you are eligible to participate in the study.
- Study Treatment Period (48 weeks). The Study Treatment period is 48 weeks.
- Safety Monitoring. For up to 30 days after the last dose of study drug.
The study may also have some unplanned visits, most commonly for repeat lab work.
Investigational Drugs
- ABBV-105 – An investigational BTK inhibitor
- Upadacitinib (ABT-494) – An investigational JAK inhibitor
- ABBV-599 – The combination of ABBV-105 and Upadacitinib
Inclusion Criteria
The following must be met in order to qualify for the study.
- Participant has clinical diagnosis of SLE at least 24 weeks prior to screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
- At Screening, must have at least one of the following:
- antinuclear antibody(ANA)+ (titer >= 1:80)
- anti-dsDNA+
- anti-Smith+
- Physician’s Global Assessment (PhGA) >= 1 during screening period
- Background treatment, stable for 30 days, at Baseline with prednisone, antimalarials, azathioprine, mycophenolate, leflunomide cyclosporine, tacrolimus, and/or methotrexate (MTX).
- The combination of background treatment with antimalarial(s) and/or prednisone (or equivalent) and a single, but not multiple, additional immunosuppressant is permitted.
Exclusion Criteria
Patients with any of the following are ineligible to enroll in the study.
- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and Dr. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.
Study Location
600 Aviator Ct.
Vandalia, OH 45377
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
1-833-STAT-833
Study Investigator
Dr. Sanford Wolfe, D.O.
Principal Investigator
Dr. Wolfe is a graduate of Des Moines University College of Osteopathic Medicine and has been practicing Rheumatology for over 40 years. Dr. Wolfe is board certified in Internal Medicine and Rheumatology. Dr. Wolfe is a renowned leader in regards to clinical research trials, with over 20 years of experience and led more than 120 studies within the Rheumatology therapeutic area.
